Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis

• Conditions: Hepatitis, Alcoholic
• Interventions: Other: Interview

• Registration Number: NCT02404636
• Lead Sponsor: University Hospital Birmingham

Brief Summary

ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:

1. Alcohol use

2. Dietary intake

3. Drug use (legal and illegal)

in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.

The study is intended to explore potential precipitants of alcoholic hepatitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-10
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• acute alcoholic hepatitis
• aged over 18 years
• able to give informed consent

Exclusion Criteria

• evidence of other acute or chronic liver disease
• episode of alcoholic hepatitis in 6 months before admission
• severe hepatic encephalopathy
• delirium

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hazardous alcohol use	Interview	Individuals admitted to hospital for any cause who drink hazardous quantities of alcohol but without evidence of alcoholic hepatitis or advanced liver disease
Alcoholic hepatitis	Interview	Individuals admitted to hospital with acute alcoholic hepatitis, defined as acute onset of jaundice in the context of recent hazardous alcohol use and the absence of other liver disease

Primary Outcome Measures

Name	Time	Method
Changes in alcohol intake, dietary intake or drug use before illness	1 month	Behavior before admission (Brief structured interview)

Secondary Outcome Measures

Name	Time	Method
Response to treatment (Brief structured interview)	1 week	Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score
Survival after admission (Brief structured interview)	12 months	Survival

Trial Locations

Locations (1)

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, West Midlands, United Kingdom